CMS Issues Pre-publication Notice for CLIA Proficiency Testing Regulations Related to Analytes and Acceptable Performance

April 2019 ~

CMS has posted a pre-publication notice, announcing a 60-day extension to the comment period for the previously proposed rule “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.”

The agency says that the decision to make the extension follows the receipt of comments and inquiries from several PT programs. According to CMS, the comments indicate the additional time to review and comment would allow an appropriate time frame to conduct a more comprehensive review in order to develop detailed responses to the technical aspects of this proposed rule given that it would represent the first comprehensive change to the PT regulations since the implementation of CLIA in 1992.

CMS says that the additional time will enable the public to prepare comments on the proposed rule and will further the overall objective to obtain public input on the potential changes related to PT that we are considering.

The comment period for the proposed rule, published February 4, 2019, was originally scheduled to end on April 5, 2019. CMS states the comment period will be extended an additional 60 days, through June 4, 2019, by 5:00 PM EDT.

Source(s): Federal Register; CMS; Rural Health;